Following days of lengthy debates, 3rd doses of the Pfizer-BioNTech COVID-19 vaccine or “boosters” can now be officially administered to certain individuals in the U.S., as endorsed by the U.S. Food and Drug Administration...more
The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more
On December 11, 2020, a SARS-CoV-2 (COVID-19) vaccine developed by Pfizer and BioNTech became the first to receive Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Since then, two others...more
On December 2, 2020, the U.K. became the first Western nation to approve the use of Pfizer/BioNTech’s COVID-19 (SARS-CoV-2) vaccine for mass inoculation. As pressure mounts on U.S. regulators to follow suit, the next 30 days...more
On October 28, 2020, CMS released an interim final rule with comment period (IFC) that implements several CARES Act requirements to prepare for the availability of a COVID-19 vaccine. Among other changes, the IFC establishes...more